MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; SEAL

Model Number	470500-14
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy procedure, a black fragment from a universal seal came off and fell into the patient.The surgeon was about ¾ completed with the procedure when a piece of the universal seal was observed to have fallen off and was viewable in the patient anatomy.The surgeon was able to retrieve the broken piece with no injury or harm to the patient.The procedure was completed without further incident.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: during the procedure, the universal seal was inspected and placed on the trocar, with no abnormalities observed at that time.The trocar, positioned in arm #4 (the surgeon's right arm), was exchanged multiple times for scissors, clips, and a needle holder instruments.It is unclear exactly when the fragment fell into the patient.The universal seal was in use for approximately 2 hours.The surgeon is uncertain what caused the piece to fall off.The port remained in place until the end of the procedure and functioned properly throughout the procedure, with no indication of a seal malfunction.The fragment was subsequently retrieved using a laparoscopic grasper, and all pieces were accounted for and confirmed at the completion of the procedure.Retrieval did not require any additional steps beyond standard practice.The operation was completed robotically, and no injury or complication resulted from the incident.The patient was discharged after 1¿2 days postoperatively, not as a result of the device issue.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the universal seal to perform failure analysis.The universal seal was found to have torn black rubber duckbill.The black rubber duckbill was torn, and although a piece was returned with the seal, some fragments may still be missing, indicating that a portion could have detached from the seal.

• Brand Name: DA VINCI
• Common Device Name: SEAL
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 24955873
• Report Number: 2955842-2026-21729
• Device Sequence Number: 15975714
• Product Code: GCJ
• UDI-Device Identifier: 10886874116408
• UDI-Public: (01)10886874116408(10)K15260211
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K181395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 470500-14
• Device Catalogue Number: 470500
• Device Lot Number: K15260211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown